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Aminosyn II Sulfite-Free News

FDA Medwatch Alert: Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot

Posted 5 Sep 2013 by

ISSUE: Hospira initiated a voluntary nationwide user-level recall of one lot (Lot# 26-138-JT ) of Aminosyn II 10%, Sulfite-Free, 500mL, NDC 0409-4164-03  due to one report of an unknown foreign particle in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. BACKGROUND: Aminosyn II 10% is an amino acid injection used as a source of nitrogen in the nutritional support of patients where oral nutrition cannot be tolerated. Lot number 26-138-JT has an expiration date of August 1, 2014 and was distributed nationwide between March 2013 and August 2013 to ... Read more

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FDA Medwatch Alert: Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals

Posted 16 Apr 2011 by

ISSUE: The Alabama Department of Public Health announced an ongoing investigation of an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition). ADPH is aware of 19 cases in these six hospitals of Serratia marcescens bacteremia related to this outbreak. BACKGROUND: CDC's initial investigation identified TPN produced by a single pharmacy, Meds IV, as a potential common source and has determined that these hospitals received TPN from this pharmacy. At this time, Meds IV recalled all of its IV compounded products. RECOMMENDATION: Remove the recalled products from Meds IV Pharmacy from shelves. Refer to the Press Release for a complete list of affected products. Healthcare professionals and patients are encouraged to report adverse ... Read more

Related support groups: Procalamine, Aminosyn, ProSol, Aminess, Clinisol Sulfite-Free, Trophamine, Aminosyn-PF, Aminosyn II, Freamine III, Parenteral Nutrition Solution W/Electrolytes, Aminosyn-RF, Renamin, Aminosyn II with Dextrose, Hepatasol, Branchamin, Travasol 5.5%, Aminosyn-HBC, Nephramine, Clinimix Sulfite Free, Travasol with Dextrose

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